United StatesCatalyft PL and PL40 Expandable Interbody System spinal cages labeled with model numbers including 6068073, 6068076, 6068093, 6068096, 6068113, 6068116, 6069073, 6069076, 6069093 and 6069096 (and corresponding GTIN/lot numbers) are affected. They were recalled because the expandable interbody system cage may lose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury; surgical technique and instructions for use will be updated to mitigate the risk.
What's being recalled
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068116. 7. SPACER 6069073 CATALYFT PL40 SHORT 7MM, Model Number: 6069073. 8. SPACER 6069076 CATALYFT PL40 LONG 7MM, Model Number: 6069076. 9. SPACER 6069093 CATALYFT PL40 SHORT 9MM, Model Number: 6069093. 10. SPACER 6069096…
Recalling firm: Medtronic Sofamor Danek USA Inc, Memphis, TN, United States.
How to identify it
IFU: M333023W048E Rev. A Surgical TechniqueM333023W217, Rev. 2.0 1. Model Number: 6068073. GTIN (Lot Numbers): 00763000246693 (0835083W, 0836192W, 0837725W, 0837727W, 0839577W, 0839579W, 0839591W, 0839593W, 0839595W, 0841459W, 0842257W, 0842767W, 0842769W, 0845001W, 0845003W, 0846533W, 0849546W, 0849548W, 0849998W, 0854451W, 0856696W, 0856698W, 0858703W, 0868179W, 0868231W, 0869637W, 0869695W, 0872240W, 0873202W, 0874502W, 0874504W, 0877435W, 0878670W, 0879342W, 0879887W, 0881316W, 0885958W, 0885960W, 0886068W, 0886070W, 0887342W, 0888799W, 0889934W, 0889936W, 0891419W, 0891951W, 0893270W, 0893332W, 0894905W, 0896952W, 0896954W, 0897308W, 0900773W, 0900970W, 0901192W, 0902362W, 0903362W, 0904350W, 0906154W, 0907656W, 0908818W, 0908820W, 0910150W, 0910202W, 0914572W, 0914574W, 0914576W, 0914578W, 0914580W, 0917478W, 0917480W, 0917662W, 0918071W, 0918073W, 0918075W, 0918077W, 0918858W, 0918860W, 0918862W, 0918864W, 0918866W, 0918886W, 0918888W, 0922033W, 0924471W, 0925397W, 0926139W, 0926361W, 0927266W, 0931914W, 0931916W, 0933069W, 0933071W, 0933073W, 0933075W, 0934823W, 0934825W, 0934827W, 0934998W, 0935000W, 0936452W, 0936454W, 0936456W, 0936458W, 0937870W, 0937872W, 0939113W, 0939115W, 0939324W, 0939326W, 0941080W, 0941364W, 0941366W, 0941912W, 0941914W, 0942912W, 0943255W, 0943257W, 0943953W, 0943955W, 0943957W, 0945701W, 0945946W, 0945948W, 0945950W, 0950146W, 0950148W, 0950150W, 0951512W, 0951514W, 0951516W, 0952750W, 0952752W, 0954062W, 0954064W, 0954430W, 0955352W, 0955892W, 0955894W, 0957547W, 0957549W, 0957551W, 0958456W, 0958458W, 0958460W, 0958854W, 0958856W, 0958858W, 0958860W, 0959360W, 0959425W, 0959427W, 0959429W, 0959431W, 0959433W, 0960482W, 0960484W, 0960486W, 0960488W, 0960490W, 0960492W, 0960494W, 0960496W, 0960498W, 0965510W, 0965512W, 0965514W, 0967296W, 0967298W, 0967300W, 0969065W, 0973081W, 0973083W, 0973837W, 0973839W, 0976737W, 0976739W, 0977571W, 0977573W, 0978651W, 0978653W, 0980738W, 0980740W, 0980752W, 0980754W, 0980756W, 0982541W…
The hazard
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Austria, Belgium, Canada, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Netherlands, New Caledonia, New Zealand, Norway, Portugal, Reunion, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)